Dec 2 (Reuters) – The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical toxicity studies for certain monoclonal antibodies.
The agency said the shift would help cut development times and reduce research and development costs, which could translate into lower drug prices.
Under current FDA requirements for monoclonal antibodies, companies conduct studies in animals to test for any harmful effects of a drug.
A typical preclinical program for a monoclonal antibody could involve more than 100 non-human primates, at a cost of roughly $50,000 per animal, the agency said.
The FDA said toxicity testing on primates that can last up to six months can now be reduced or eliminated, and that it is incorporating other types of risk assessments into its decision-making.
“Modern science has given us far more effective and humane ways of evaluating drug safety than animal testing,” FDA Commissioner Marty Makary said in a statement.
The agency had in April outlined a road map for companies to reduce reliance on animal testing, especially for monoclonal antibody drugs.
(Reporting by Mrinalika Roy and Anusha Shah in BengaluruEditing by Bernadette Baum and Anil D’Silva)
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